Sr. Safety Specialist
Found in: Talent IN C2 - 3 weeks ago
Sr. Safety Specialist
SDC is a team of diversified professionals who deliver exceptional Biometric Services, Consulting, and Technology Solutions to pharmaceutical, biologic, and medical device/diagnostic companies. Since 2005 our purpose has been to partner with sponsors to provide high quality and experienced team members to develop great medicines that save lives and cure diseases in the most efficient manner possible. Our global team operates as a value partner to our clients by fulfilling their needs as our own and delivering exceptional results. We are a specialty CRO in that we provide scalable service offerings, focused services area specialists, efficient project timelines, optimal technology solutions, and proven success and experience. Our commitment to our clients is the same commitment to our employees. By offering strong benefits including competitive pay, generous time off, attainable career advances and positive work/life balance, we are able to attract some of the most talented people in the industry.
Job Summary:
The Sr. Safety Specialist will support safety/pharmacovigilance (PV) operations activities including vendor oversight. They will assist in developing and implementing safety/PV guidelines and ensures the uniform and timely processing of adverse events and compliance within standard operating procedures (SOPs), Global, Federal, State, and local safety regulations. They will provide technical and safety-related regulatory assistance to study teams. Additionally, the Sr. Safety Specialist will be involved in risk-assessment work and will write, and/or sign-off on, documentation when created.
Primary Responsibilities
•Applies Knowledge and Experience of Clinical Safety/PV to a wide range of clinical research studies in one or more therapeutic areas (e.g., Oncology, Ophthalmology)
•Coordinates and performs adverse event data entry, coding and assessment of adverse events, case review, follow-up, tracking of reports, and regulatory reporting activities to comply with protocol and regulatory specific requirements.
•Prepare for expedited reporting of SAEs, including preparation of analysis of similar events.
•Support the preparation of periodic safety reports in accordance with regulatory requirements and SOPs.
•Escalates potential patient safety issues to Sr. Leadership.
•Works closely with management and study teams to produce clear and concise communication of complex data.
•Acts as liaison to vendor for case processing activities and ensures adherence to processes and regulatory requirements.
•Supports safety database activities as needed.
•Seeks opportunities for continuous quality improvement.
•Other duties as assigned.
The above statements describe the general nature and level of work being performed by individuals assigned to this classification. This document is not intended to be an exhaustive list of all responsibilities and duties required of personnel so classified.
Requirements
Required Skills
•Ability to think analytically and process, evaluate, interpret, and synthesize scientific and medical data.
•Must possess ability to work and make decisions independently, understand complex medical information and be able to take initiative and lead projects and assignments.
•Excellent organizational, project and time management skills.
•Excellent working knowledge of ICH guidelines, US and EU pharmacovigilance regulatory requirements, and medical terminology.
•Strong technical writing, editing, and proof-reading skills.
•Strong vendor management skills.
•Knowledge of drug safety systems (e.g., ARISg, Argus, ABcube).
•Ability to meet multiple deadlines with a high degree of accuracy and efficiency.
•Self-motivated, detail oriented, and able to prioritize and plan effectively.
•Strong technical skills software skills (e.g., MS Word, MS Excel).
Education or Equivalent Experience
•BS/BA in a scientific field or 6+ years of pharmacovigilance or safety case processing for clinical trials is required
•CRO experience preferred.
•Master’s degree in scientific field and 3+ years of pharmacovigilance is preferred.
•Experience in and knowledge of drug safety databases (e.g., ARISg, Argus, ABcube Safety Easy), signal evaluation and risk management, aggregate data analysis, interpretation, synthesis, and authoring periodic aggregate safety reports (e.g., PBRERs, DSURs).
Why SDC
We are committed to developing our employees. We recognize achievements, provide growth opportunities and career advancement, offer a flexible work schedule, engaging work culture and employee benefits.
We are passionate about our company culture. Our recognition program is directly tied to our core values of Energy, Integrity, Engagement, Innovation, Ownership, and Commitment.
We strive to provide a place of belonging to our employees with fun and engaging activities from SDC’s culture club.
We are constantly growing and innovating to support our client and employee needs. Global in nature, we bring diverse perspectives enabling our growth in this ever-evolving industry.
With a proven track record, SDC has been successfully executing client clinical programs since 2005.
Take a look at how you can join our team
-
Safety Specialist
Found in: Talent IN C2 - 3 weeks ago
Hyderabad, India Thermo Fisher Scientific Full timePerforms day-to-day Pharmacovigilance (PV) activities performed within a highly regulated environment and driven by strict timelines. Pharmacovigilance activities include but are not limited to collection, monitoring, assessment, evaluation, research and tracking of safety information. Coordinates and performs Pharmacovigilance activities such as data...
-
Safety Specialist
Found in: beBee S IN - 3 weeks ago
Hyderabad, India Thermo Fisher Scientific Full timeJob DescriptionJob DescriptionPerforms day-to-day Pharmacovigilance (PV) activities performed within a highly regulated environment and driven by strict timelines. Pharmacovigilance activities include but are not limited to collection, monitoring, assessment, evaluation, research and tracking of safety information. Coordinates and performs...
-
Sr. Specialist Lead, Account Health Support
Found in: Talent IN C2 - 3 weeks ago
Hyderabad, India Amazon Dev Center India - Hyderabad Full timeSr. Account Health Sr. Specialist Leads utilize extensive knowledge, experience, and judgment to provide operational support to Specialist, Ops Managers and Sellers. They handle Seller escalations, assist Operations with supplemental Specialist coaching focused on specific behaviors for improvement, and assistance Specialists with real time needs. They...
-
Safety Specialist
Found in: beBee jobs IN - 1 week ago
Hyderabad, Telangana, India Thermo Fisher Scientific Full timeJob DescriptionJob DescriptionPerforms day-to-day Pharmacovigilance (PV) activities performed within a highly regulated environment and driven by strict timelines. Pharmacovigilance activities include but are not limited to collection, monitoring, assessment, evaluation, research and tracking of safety information. Coordinates and performs Pharmacovigilance...
-
Safety Specialist
Found in: beBee S IN - 4 weeks ago
Hyderabad, India Thermo Fisher Scientific Full timeJob DescriptionPerforms day-to-day PV activities. May participate in on-call duties for specific projects to ensure 24-hr coverage for intake of cases from investigative sites.Reviews regulatory/pharmacovigilance publications and information sources to keep updated on current regulations, practices, procedures and proposals.Maintains medical understanding of...
-
Drug Safety Associate
Found in: beBee S IN - 4 weeks ago
Hyderabad, India Parexel Full timeKey Accountabilities:Drug Safety Support:Assist in development of project specific safety procedures, workflows and templateAssist in project specific safety database setup, development of data entry guidelines, and user acceptance testingTriage incoming reports for completeness, legibility, and validityElectronic documentation and quality control of drug...
-
Sr Engineer- AGL
Found in: Talent IN C2 - 3 weeks ago
Hyderabad, India GMR Group Full timeJOB PURPOSE Operation & Maintenance of Security & Surveillance systems of Airside Landside at RGIA in a safe cost effective manner with adherence to the rules of BCAS. Support in Operate and maintenance of Airfield Ground Lighting and Security System and ensuring 100% availability on 24X7 basis for uninterrupted operations of RGIA as per DGCA/ICAO...
-
sr. business services specialist.
2 weeks ago
Hyderabad / Secunderabad, Telangana, India Randstad Full timeRole: Senior Business Services Specialist, Source & Screen (RC/ Sourcing Admin)Location: Hyderabad, TelanganaEmployment: Full TimeAs a Sr. Business Services Specialist, you will contribute to a collaborative talent acquisition environment to ensure efficient delivery support for our internal clients/ customers, drive the processes that help us screen and...
-
Environment, Health and Safety Manager
Found in: Appcast Linkedin IN C2 - 1 day ago
Hyderabad, India Hammond Power Solutions Full timeThe position is responsible for planning, developing, implementing and directing health and safety programs and activities throughout the Company to evaluate, prevent, control, or correct unsafe physical and environmental working condition and hazards.The job responsibilities include:Safety related upgrades/changes with the Manufacturing Engineering group...
-
Environment, Health and Safety Manager
Found in: Talent IN 2A C2 - 9 hours ago
Hyderabad, India Hammond Power Solutions Full timeThe position is responsible for planning, developing, implementing and directing health and safety programs and activities throughout the Company to evaluate, prevent, control, or correct unsafe physical and environmental working condition and hazards.The job responsibilities include:Safety related upgrades/changes with the Manufacturing Engineering group...
-
Immigration Specialist
Found in: Whatjobs IN C2 - 7 days ago
hyderabad, India SRS Consulting Inc Full timeJob Title: US Immigration Specialist Job Type: Permanent Shift: Night shift Location: Madhapur, Hitech City. Must have experience: 1 - 3 years. We are inviting applications from experienced candidates who wish to join with SRS Consulting Inc.as a US Immigration Specialist for our Hyderabad office. Who are we? SRS Business Solutions India Pvt. Ltd is...
-
Immigration Specialist
Found in: Talent IN 2A C2 - 7 days ago
Hyderabad, India SRS Consulting Inc Full timeJob Title: US Immigration Specialist Job Type: Permanent Shift: Night shift Location: Madhapur, Hitech City.Must have experience: 1 - 3 years.We are inviting applications from experienced candidates who wish to join with SRS Consulting Inc.as a US Immigration Specialist for our Hyderabad office.Who are we?SRS Business Solutions India Pvt. Ltd is a subsidiary...
-
Immigration Specialist
Found in: Appcast Linkedin IN C2 - 7 days ago
Hyderabad, India SRS Consulting Inc Full timeJob Title: US Immigration Specialist Job Type: Permanent Shift: Night shift Location: Madhapur, Hitech City.Must have experience: 1 - 3 years.We are inviting applications from experienced candidates who wish to join with SRS Consulting Inc.as a US Immigration Specialist for our Hyderabad office.Who are we?SRS Business Solutions India Pvt. Ltd is a subsidiary...
-
Sr Team Manager, Escalated Care Specialists
Found in: beBee jobs IN - 7 days ago
Hyderabad, Telangana, India Electronic Arts Full timeSr Team Manager, Differentiated Escalation Specialists-EA Fan Care Are you passionate about creating great experiences for our fans?EA's Fan Care organization exists to help the world to play. We help our players wherever they are, whenever they need, get the most from their games. We aim to make EA known for taking care of its players.And we'd like you to...
-
Immigration Specialist
Found in: Whatjobs IN C2 - 4 days ago
Hyderabad, India SRS Consulting Inc Full timeJob Title:US Immigration SpecialistJob Type:PermanentShift:Night shiftLocation:Madhapur, Hitech City.Must have experience:1 - 3 years.We are inviting applications from experienced candidates who wish to join with SRS Consulting Inc.as a US Immigration Specialist for our Hyderabad office.Who are we?SRS Business Solutions India Pvt. Ltd is a subsidiary of SRS...
-
Senior Functional Safety Specialist/Engineer
Found in: Talent IN C2 - 5 days ago
Hyderabad, India QNX Software Systems Full timeWorker Sub-Type:Regular Job Description: Location: On-site Hyderabad BlackBerry® QNX® is a trusted supplier of safe and secure operating systems, hypervisors, frameworks and development tools, and provides expert support and services for building the world’s most critical embedded systems. We are the embedded experts. BlackBerry QNX was born in...
-
Safety Specialist III
Found in: Talent IN C2 - 3 weeks ago
Hyderabad, India Thermo Fisher Scientific Full timeSummarized Purpose: Performs and may oversee day-to-day Pharmacovigilance (PVG) activities performed within a highly regulated environment and driven by strict timelines. Pharmacovigilance activities include but are not limited to collection, monitoring, assessment, evaluation, research and tracking of safety information. Effectively...
-
Sr Team Manager, Escalated Care Specialists
Found in: beBee S IN - 7 days ago
Hyderabad, India Electronic Arts Full timeSr Team Manager, Differentiated Escalation Specialists-EA Fan Care Are you passionate about creating great experiences for our fans? EA’s Fan Care organization exists to help the world to play. We help our players wherever they are, whenever they need, get the most from their games. We aim to make EA known for taking care of its players. And we'd like...
-
Specialist/Senior Specialist
Found in: beBee jobs IN - 2 weeks ago
Hyderabad/Gurgaon/Gurugram, India iimjobs Full timeGlobal recognized leader in Financial & Technology based firm with Offices in New York, Hong Kong, Hyderabad (India), Kansas City, London and Silicon Valley is looking for resourceful candidates to join its Talent Acquisition team.Join a company that is recognized as a paymaster, where your skills will be valued, and you'll have the opportunity to make a...
-
Source to Contract Administrative Specialist
Found in: Whatjobs IN C2 - 4 days ago
Hyderabad, India TJX Global IT India Full timeWhat you will discover ? Inclusive culture and career growth opportunities Global Organization which collaborates across U.S., Canada, Europe, Australia and India Challenging, collaborative, and team-based environment What you will do ? The TJX Global Sourcing and Procurement (GS&P) organization is the cornerstone of efficiency and excellence across our...